Description: Prepare and review qualification protocols and reports for equipment, utilities, and systems (DQ, IQ, OQ, PQ, as applicable). Coordinate and monitor qualification activities with Engineering, Production, and Validation teams. Ensure qualification documentation complies with GMP and regulatory
Lead and maintain the Pharmaceutical Quality System (PQS) by establishing, implementing, monitoring, and continuously improving quality systems in compliance with ICH Q7, ICH Q9(R1), ICH Q10, applicable cGMP regulations, and company quality policies to ensure a state of
Role Objective A key objective of this position is to lead and govern the Quality function at the manufacturing site, ensuring uncompromised product quality, patient safety, and compliance with global regulatory requirements (USFDA, EU-GMP, MHRA, WHO-GMP,